| Product |
Company |
Generic name |
KEGG DRUG |
|
Ipratropium Bromide solution .5 mg/2.5mL (ANDA)
|
Chartwell RX, LLC |
Ipratropium Bromide |
D02212
|
|
IMDELLTRA (AMG757) kit (BLA)
|
Amgen, Inc |
Tarlatamab-dlle |
D12234
|
|
Pregnyl kit (BLA)
|
Organon LLC |
CHORIOGONADOTROPIN ALFA |
D06457
|
|
Naltrexone Hydrochloride tablet, film coated 50 mg (ANDA)
|
AvKARE |
Naltrexone Hydrochloride |
D02095
|
IMULDOSA injection 45 mg/.5mL (BLA)
IMULDOSA injection 90 mg/mL (BLA)
IMULDOSA injection 130 mg/26mL (BLA)
|
Accord BioPharma Inc. |
ustekinumab-srlf |
D09214
|
|
Vandazole gel 7.5 mg/g (NDA)
|
Upsher-smith Laboratories, LLC |
Metronidazole |
D00409
|
CYCLOPHOSPHAMIDE injection, powder, for solution 500 mg/25mL (ANDA)
CYCLOPHOSPHAMIDE injection, powder, for solution 1 g/50mL (ANDA)
CYCLOPHOSPHAMIDE injection, powder, for solution 2 g00mL (ANDA)
|
Bamboo US Bidco LCC |
cyclophosphamide |
D00287
|
|
oxygen gas 995 mL/L (NDA)
|
Shaw Oxygen Company Inc |
oxygen |
D00003
|
|
Metronidazole tablet, film coated 500 mg (ANDA)
|
A-S Medication Solutions |
Metronidazole |
D00409
|
|
Erythromycin ointment 5 mg/g (ANDA)
|
A-S Medication Solutions |
Erythromycin |
D00140
|
|
Megestrol Acetate suspension 125 mg/mL (ANDA)
|
Upsher-Smith Laboratories, LLC |
Megestrol Acetate |
D00952
|
|
Albuterol Sulfate Inhalation inhalant 90 ug (ANDA)
|
Amneal Pharmaceuticals NY LLC |
Albuterol Sulfate |
D00683
|
|
Nitrogen gas 990 mL/L (NDA)
|
Machine & Welding Supply Company dba Arc3 Gases South |
Nitrogen |
D00083
|
MEROPENEM injection 500 mg/20mL (ANDA)
MEROPENEM injection 1 g/30mL (ANDA)
|
Savior Lifetec Corporation |
MEROPENEM |
D02222
|
|
Albuterol Sulfate aerosol, metered 108 ug (NDA AUTHORIZED GENERIC)
|
REMEDYREPACK INC. |
Albuterol Sulfate |
D00683
|
Metformin Hydrochloride tablet, coated 1000 mg (ANDA)
Metformin Hydrochloride tablet, coated 850 mg (ANDA)
Metformin Hydrochloride tablet, coated 500 mg (ANDA)
|
Precision Dose, Inc. |
Metformin Hydrochloride |
D00944
|
Venlafaxine Hydrochloride tablet 25 mg (ANDA)
Venlafaxine Hydrochloride tablet 37.5 mg (ANDA)
Venlafaxine Hydrochloride tablet 50 mg (ANDA)
Venlafaxine Hydrochloride tablet 75 mg (ANDA)
Venlafaxine Hydrochloride tablet 100 mg (ANDA)
|
Yaopharma Co., Ltd. |
venlafaxine hydrochloride |
D00821
|
|
Azithromycin Dihydrate tablet, film coated 500 mg (ANDA)
|
Precision Dose, Inc. |
Azithromycin dihydrate |
D02134
|
Nifedipine tablet, extended release 90 mg (ANDA)
Nifedipine tablet, extended release 60 mg (ANDA)
Nifedipine tablet, extended release 30 mg (ANDA)
|
Upsher-Smith Laboratories, LLC |
Nifedipine |
D00437
|
|
Mulpleta tablet, film coated 3 mg (NDA)
|
Eddingpharm (U. S. ) Inc. |
Lusutrombopag |
D10476
|
|
Clindamycin Hydrochloride capsule 300 mg (ANDA)
|
VERITYRX, LLC |
Clindamycin Hydrochloride |
D02132
|
|
nitrofurantoin macrocrystals capsule 100 mg (ANDA)
|
VERITYRX, LLC |
nitrofurantoin macrocrystals |
D00439
|
|
Cyclobenzaprine Hydrochloride tablet, film coated 5 mg (ANDA)
|
NuCare Pharmaceuticals, Inc. |
Cyclobenzaprine Hydrochloride |
D00772
|
|
HYDROXYUREA capsule 500 mg (ANDA)
|
Coupler LLC |
HYDROXYUREA |
D00341
|
|
Helium gas 990 mL/L (NDA)
|
Machine & Welding Supply Company dba Arc3 Gases South |
Helium |
D04420
|
|
SIMVASTATIN tablet, film coated 10 mg (ANDA)
|
Aphena Pharma Solutions - Tennessee, LLC |
SIMVASTATIN |
D00434
|
|
Oxaprozin capsule 300 mg (NDA)
|
SOLA Pharmaceuticals, LLC |
Oxaprozin |
D00463
|
|
Lisinopril/HCTZ tablet 12.5 mg (ANDA)
|
Direct_Rx |
Lisinopril/HCTZ |
D10268
|
Hadlima solution 40 mg/.8mL (BLA)
Hadlima solution 40 mg/.4mL (BLA)
|
Organon LLC |
adalimumab-bwwd |
D02597
|
Bupropion hydrochloride tablet 150 mg (ANDA)
Bupropion hydrochloride tablet 300 mg (ANDA)
|
BluePoint Laboratories |
Bupropion hydrochloride |
D00817
|
|
PANRETIN gel 60 mg/60g (NDA)
|
Advanz Pharma (US) Corp. |
alitretinoin |
D02815
|
|
Oxygen gas 995 mL/L (NDA)
|
Gas and Supply |
Oxygen |
D00003
|
|
Etoposide injection, solution, concentrate 20 mg/mL (ANDA)
|
Meitheal Pharmaceuticals Inc. |
Etoposide |
D00125
|
|
indomethacin capsule, extended release 75 mg (ANDA)
|
Glenmark Pharmaceuticals Inc., USA |
indomethacin |
D00141
|
AMLODIPINE BESYLATE tablet 2.5 mg (ANDA)
AMLODIPINE BESYLATE tablet 5 mg (ANDA)
AMLODIPINE BESYLATE tablet 10 mg (ANDA)
|
Cipla USA Inc. |
AMLODIPINE BESYLATE |
D00615
|
|
Amoxicillin for suspension 400 mg/5mL (NDA AUTHORIZED GENERIC)
|
REMEDYREPACK INC. |
Amoxicillin |
D00229
|
|
Dexycu injection, suspension 517 ug/.005mL (NDA)
|
EyePoint Pharmaceuticals US, Inc |
dexamethasone |
D00292
|
|
Nitrogen gas 995 mL/L (NDA)
|
Gas and Supply |
Nitrogen |
D00083
|
Metformin Hydrochloride tablet, extended release 750 mg (ANDA)
Metformin Hydrochloride tablet, extended release 500 mg (ANDA)
|
Precision Dose, Inc. |
Metformin Hydrochloride |
D00944
|
|
Metronidazole tablet, film coated 500 mg (ANDA)
|
A-S Medication Solutions |
Metronidazole |
D00409
|